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Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program

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Summary

NIH has registered a new clinical trial (NCT07534254) evaluating the feasibility of integrating a generative AI chatbot into a 12-week smartphone-based behavioral weight loss program for young adults. The study will compare standard program delivery (1-2 brief daily messages) against the same program enhanced with an AI chatbot offering additional behavior change support. Participants will be assessed on program feasibility, acceptability, engagement, and weight change outcomes.

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What changed

NIH has added a new clinical trial registration describing a pilot study evaluating a generative AI chatbot embedded within an existing mobile behavioral weight loss program (AGILE) for young adults aged 18-35 with overweight or obesity. The 12-week randomized comparison will assess whether chatbot integration improves program feasibility, participant acceptability, engagement rates, and weight change compared to standard brief daily message delivery alone.

This study registration does not impose compliance obligations on regulated entities. Healthcare providers, technology companies developing similar AI-enhanced wellness applications, or researchers conducting digital health interventions may find the study design and outcomes relevant for future program development, though no regulatory action is required at this time.

Archived snapshot

Apr 16, 2026

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Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program

N/A NCT07534254 Kind: NA Apr 16, 2026

Abstract

The goal of this study is to learn if integrating a chatbot into an existing 12-week smartphone-delivered behavioral weight loss program is feasible and effective for weight loss among young adults. Researchers will compare a standard behavioral weight loss program for young adults that delivers 1-2 brief messages per day (AGILE) to the same program with a chatbot integrated into the app that will offer additional behavior change support (AGILE + Chatbot) to see if the program with the chatbot is feasible, acceptable to participants, and improves program engagement and weight change.

Conditions: Overweight and/or Obesity

Interventions: AGILE Intervention, Chatbot

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534254

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Digital health intervention Behavioral health research
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Artificial Intelligence Healthcare

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